EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2023/2697  
[…](2024) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION IMPLEMENTING REGULATION (EU) .../...  
renewing the approval of the active substance metconazole as a candidate for 
substitution in accordance with Regulation (EC) No 1107/2009 of the European 
Parliament and of the Council, and amending Commission Implementing Regulation 
(EU) No 540/2011    
EN 2  EN ANNEX I  
 
Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
metconazole  
CAS No: 
125116 -23-6 
(unstated 
stereochemistry)  
CIPAC No: 706 
 (1RS,5RS:1RS,5SR)
-5-(4-chlorobenzyl) -
2,2-dimethyl -1-(1H-
1,2,4 -triazol -1-
ylmethyl)cyclopenta
nol 940≥   g/kg (sum 
of cis - and trans -
isomers), with 
cis-metconazole 
(CL 354801) 
level not  less than 
800 g/kg and not 
more than 950 
g/kg 
 
The following 
impurities shall 
not exceed the 
following levels 
in the technical 
material:  
- toluene : 2 g/kg 
- 
ethylcyclohexane : 
2 g/kg 
 1 September  2024   31 August  2031  Use shall be limited to  professional users . 
 
For the implementation of the uniform principles as referred to in 
Article  29(6) of Regulation (EC) No  1107/2009, the conclusions of 
the re newal  report on metconazole , and in particular Appendices  I 
and II thereto , shall be taken into  account.  
 
In this overall assessment Member States shall pay particular 
attention to:  
 the consumer exposure assessment with regards to residues that 
may be present in the primary crops and succeeding crops grown 
in rotation;  
 the protection of operators and bystanders/residents ; 
 the protection of aquatic organisms . 
 
Conditions of use shall include risk mitigation measures, where 
appropriate.  
 
The applicant shall submit confirmatory information as regards:  
1. the effect of water treatment processes on the nature of residues 
present in surface water and groundwater, when surface water or 
groundwater is abstracted for drinking water ; 
2. the general toxicity profile of the metabolites M11 and M21 
should be further investigated in order to confirm the appropriate 
toxicological reference values applicable to them. Moreover, 
confirmation of the presence of M11 and M21 and their ratio 
among th e monohydroxylated metconazole compounds in crops, 
in order to confirm the residue definition for risk assessment.  
                                                 
1 Further details on the identity and specification of the active substance are provided in the re newal  report .  
EN 3  EN Common Name,  
Identification 
Numbers  IUPAC Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
 
The applicant shall submit the confirmatory information referred to 
in point 1 w ithin two years after the date on which the relevant 
guidance document will become applicable  and in point 2 by  [Office of 
Publications please insert the date two years  from the date of entry 
into force of th is Regulation]  to the Commission, Member States and 
the Authority .  
EN 4  EN ANNEX II 
The Annex to Commission Implementing Regulation (EU) No 540/2011  is amended as follows:  
 
(1) in Part A, entry 134 on metconazole  is deleted;  
(2) in Part E, the following entry is added : 
 
No Common Name,  
Identification 
Numbers  IUPAC 
Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
“xx metconazole  
CAS No: 125116 -
23-6 (unstated 
stereochemistry)  
CIPAC No: 706  
 (1RS,5RS:1R
S,5SR)-5-(4-
chlorobenzyl
)-2,2-
dimethyl -1-
(1H-1,2,4 -
triazol -1-
ylmethyl)cyc
lopentanol  940≥    g/kg (sum of 
cis- and trans -
isomers), with cis -
metconazole (CL 
354801) level not 
less than 800 g/kg 
and not more than 
950 g/kg  
 
The following 
impurities shall not 
exceed the following 
levels in the 
technical material:  
- toluene: 2 g/kg  
- ethylcyclohexane: 
2 g/kg  1 September  2024  31 August  2031  Use shall be limited to professional users . 
 
For the implementation of the uniform principles as referred to in 
Article  29(6) of Regulation (EC) No  1107/2009, the conclusions of the 
renewal  report on metconazole , and in particular Appendices  I and II 
thereto , shall be taken into account.  
 
In this overall assessment Member States shall pay particular attention to:  
 
 the consumer exposure assessment with regards to residues that may 
be present in the primary crops and succeeding crops grown in 
rotation;  
 the protection of operators and bystanders/residents ; 
 the protection of aquatic organisms . 
 
Conditions of use shall include risk mitigation measures, where 
appropriat e. 
 
The applicant shall submit confirmatory information as regards:  
1. the effect of water treatment processes on the nature of residues 
present in surface water and groundwater, when surface water or 
groundwater is abstracted for drinking water ; 
                                                 
1 Further details on the identity and specification of the active substance are provided in the re newal  report .  
EN 5  EN No Common Name,  
Identification 
Numbers  IUPAC 
Name  Purity1 Date of approval  Expiration of 
approval  Specific provisions  
2. the ge neral toxicity profile of the metabolites M11 and M21 should 
be further investigated in order to confirm the appropriate 
toxicological reference values applicable to them. Moreover, 
confirmation of the presence of M11 and M21 and their ratio among 
the mono hydroxylated metconazole compounds in crops, in order to 
confirm the residue definition for risk assessment.  
 
The applicant shall submit the confirmatory information referred to in 
point 1 w ithin two years after the date on which the relevant guidance 
document will become applicable  and in point 2 by  [Office of Publications 
please insert the date two years  from the date of entry into force of th is 
Regulation]  to the Commission, Member States and the Authority .